Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
NCT ID: NCT00697970
Last Updated: 2008-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
321 participants
INTERVENTIONAL
1993-11-30
1995-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group A
HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Group B
HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Group C
HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Group D
HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Group E
HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Group F
Engerix™-B
Intramuscular injection, 3 doses
Interventions
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HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Engerix™-B
Intramuscular injection, 3 doses
Eligibility Criteria
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Inclusion Criteria
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.
Exclusion Criteria
* Positivity for anti hepatitis antibodies.
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Administration of any other vaccine(s) or any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial
18 Years
40 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Clinical Trials Call Center
Vienna, , Austria
Countries
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Other Identifiers
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208129/006
Identifier Type: -
Identifier Source: org_study_id